NCT04681404
Recruiting
Not Applicable
Assessment of Balance, Function and Quality of Life in Patients Before and After Knee Replacement
Johannes Kepler University of Linz1 site in 1 country150 target enrollmentJanuary 11, 2021
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Postural Balance
- Sponsor
- Johannes Kepler University of Linz
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- Center of pressure track (COPT)
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
Evaluation of patients before and after knee arthroplasty regarding balance, function and quality of life. Comparison of total and unicompartmental knee arthroplasty. Comparison of the primary outcome parameter and selected secondary outcome parameters to healthy controls.
Investigators
Christian Mittermaier
Christian Mittermaier, MD
Johannes Kepler University of Linz
Eligibility Criteria
Inclusion Criteria
- •Primary gonarthrosis
- •planned TKA or UKA
- •adequate cognitive and lingual competence
- •informed consent
Exclusion Criteria
- •TKA or UKA revision
- •Surgery after trauma
- •Rheumatic disease
- •Neurologic disease
- •previous arthroplasty of the lower extremity (\<9 months)
- •cardiovascular disease
- •restricted weight bearing of the lower extremity after surgery
Outcomes
Primary Outcomes
Center of pressure track (COPT)
Time Frame: 1 year after surgery
Posturographic Parameter
Secondary Outcomes
- Oxford Knee Score(Before surgery; 1 year after surgery)
- Frequency of Sway(Before surgery; day 3-7 after surgery; 3 months and 1 year after surgery)
- WOMAC Score(Before surgery; 1 year after surgery, higher score means better outcome)
- Functional reach test(Before surgery; day 3-7 after surgery; 3 months and 1 year after surgery)
- Timed up and go - test(Before surgery; day 3-7 after surgery; 3 months and 1 year after surgery)
- Forgotten Joint Score(Before surgery; 1 year after surgery)
- Knee Injury and Osteoarthritis Outcome Score(Before surgery; day 3-7 after surgery; 3 months and 1 year after surgery)
- EQ-5D - Score(Before surgery; 1 year after surgery)
- 10 m Walking test(Before surgery; day 3-7 after surgery; 3 months and 1 year after surgery)
- Knee Society Score(Before surgery; 1 year after surgery)
- The University of California at Los Angeles Activity Score(Before surgery; 1 year after surgery)
- Area of Sway(Before surgery; day 3-7 after surgery; 3 months and 1 year after surgery)
- Harmony Index(Before surgery; day 3-7 after surgery; 3 months and 1 year after surgery)
- Stability energy(Before surgery; day 3-7 after surgery; 3 months and 1 year after surgery)
- Movement control(Before surgery; day 3-7 after surgery; 3 months and 1 year after surgery)
- Feedback (visual, somatosensoric, vestibular)(Before surgery; day 3-7 after surgery; 3 months and 1 year after surgery)
- Weight Distribution Index(Before surgery; day 3-7 after surgery; 3 months and 1 year after surgery)
- Fulfillment of Tests(Before surgery; day 3-7 after surgery; 3 months and 1 year after surgery)
Study Sites (1)
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